Synchronous external electrical activity

Abstract

Described herein are systems and methods for synchronizing electrical activity monitored by a plurality of external electrodes with supplemental cardiac data for assessing a patient's cardiac condition and configuring cardiac therapy. The supplemental cardiac data can include one or more markers indicative of a cardiac event occurrence and / or representative of at least one of a cardiac electrical signal, a heart sound, a cardiac pressure, a blood flow, and an estimated instantaneous flow waveform provided by a left ventricular assist device.

Description

[0001] The disclosure herein relates to systems and methods for synchronizing electrical activity monitored by multiple external electrodes with supplemental cardiac data for assessing a patient’s cardiac condition and configuring cardiac therapies.

[0002] In addition to the implantable medical device itself, systems used to configure the device and assess a patient's cardiac condition may include workstations or other devices. In some cases, these other devices assist physicians or other technicians in placing intracardiac leads at specific locations on or within the heart. In other cases, the device provides physicians with information about the heart's electrical activity and the location of the intracardiac leads. Summary of the Invention

[0003] The exemplary systems and methods described herein can be configured to assist a user (e.g., a physician) in assessing and configuring cardiac therapies (e.g., cardiac therapies being performed on a patient during and / or after implantation of a cardiac therapy device). In one or more embodiments, the electrode devices of these systems and methods can be described as non-invasive because such electrode devices can perform electrical measurements non-invasively using, for example, multiple external electrodes attached to the patient's skin around the patient's torso.

[0004] These exemplary systems and methods can be described as being configured to connect implantable cardiac device tagging data and other data to external sensor instruments or another implantable device. Integrating implantable cardiac device tagging with external sensor instruments can have many different applications in enhancing various capabilities for better detection and diagnosis. For example, an implantable cardiac device may include a sensing amplifier for detecting inherent activity in different chambers of the heart, and timing tags for delivering pacemakers to certain chambers of the heart via one or more leads or devices. Synchronizing data with external sensor systems and instruments can aid in detection and subsequent diagnosis.

[0005] For example, an "ECG band" is an external surface mapping system comprising multiple external ECG sensors / electrodes positioned on the patient's torso. Understanding the timing of ventricular pacing events from the device (e.g., left ventricular pacing) can help the external surface mapping system "blind" or have other mechanisms to eliminate data for a period of time after pacing (e.g., 5 ms) to eliminate potential artifacts in the external electrical signal. Furthermore, it can also help detect the onset of the depolarization (QRS) complex during ventricular pacing and ventricular sensing from the device. Other implantable device data (e.g., pacing programming parameters) can also be integrated during the recording and / or processing of external sensor (in this case, ECG) data to aid in data annotation.

[0006] These exemplary systems and methods can be configured to synchronize an external sensor system (e.g., an ECG band system) with labeled timing and other programmed data from an implantable cardiac device (e.g., a cardiac resynchronization therapy device). Further, these exemplary systems and methods can use labeled data (e.g., atrial sensing AS, atrial pacing AP, ventricular sensing VS, ventricular pacing VP, effective capture E, ineffective capture I) to annotate portions of the ECG recording from the external sensor system and aid in detection and diagnosis. For example, QRS initiation detection can be enhanced based on VP / VS labeling. Further, for example, pacing artifacts can be avoided by blanking or other means for a period of time after ventricular pacing delivery, particularly after left ventricular pacing (e.g., approximately 5 milliseconds (ms) to approximately 10 ms). Even further, for example, when processing electrical heterogeneity information (e.g., asynchrony information) during LV pacing or biventricular pacing, cardiac cycles / events labeled as VS or ineffective pacing (I) by the device can be eliminated or “excluded.”

[0007] These exemplary systems and methods can also annotate external sensor data to label various cardiac events, such as, for example, atrial depolarization labeled based on AS / AP, ventricular depolarization labeled based on VP / VS, and the interval between the A event and the next subsequent V event labeled with the AV interval. Furthermore, these exemplary systems and methods can combine non-ECG sensor data (such as external pressure sensor data or external acoustic sensor data) of ECG activity monitored by multiple external electrodes to visualize and calculate the timing of device sensing or pacing relative to the timing of certain mechanical events (such as the closure of heart valves or the onset of ventricular systole, diastole, etc.). Even further, these exemplary systems and methods can synchronize ECG activity monitored by multiple external electrodes with data from another implanted device (e.g., waveforms from a left ventricular assist device (LVAD)). These exemplary systems and methods can then be used to adjust cardiac therapy based on the electromechanical timing provided by the supplemental ECG activity. For example, pacing parameters can be optimized to shorten the interval between pacing delivery timing and the onset of systole, or to maximize ejection time (e.g., the duration of systole).

[0008] An exemplary system for cardiac assessment may include: an electrode device comprising a plurality of external electrodes for monitoring electrical activity from patient tissue; a communication interface for receiving cardiac information from at least one medical device; and a computing device including processing circuitry and operatively coupled to the electrode device and the communication interface. The computing device may be configured to monitor electrical activity using the plurality of external electrodes, receive supplemental cardiac data from at least one medical device via the communication interface, and synchronize the monitored electrical activity or data based on the monitored electrical activity with the supplemental cardiac data to generate synchronized cardiac information.

[0009] An exemplary method for cardiac assessment may include monitoring electrical activity from patient tissue using multiple external electrodes, receiving supplemental cardiac data from at least one medical device, and synchronizing the monitored electrical activity or data based on the monitored electrical activity with the supplemental cardiac data to generate synchronized cardiac information.

[0010] An exemplary system for cardiac assessment may include: an electrode device comprising a plurality of external electrodes for monitoring electrical activity from patient tissue; a communication interface for receiving cardiac information from at least one medical device; a display including a graphical user interface for presenting information to assist the user in assessing at least one of the following: assessing a patient's cardiac health and evaluating and adjusting cardiac therapies delivered to the patient; and a computing device including processing circuitry and operatively coupled to the electrode device and the communication interface. The computing device may be configured to monitor electrical activity using the plurality of external electrodes, receive supplemental cardiac data from at least one medical device via the communication interface, synchronize the monitored electrical activity or data based on the monitored electrical activity with the supplemental cardiac data to generate synchronized cardiac information, and display on the graphical user interface at least a portion of the monitored electrical activity or data annotated thereon with at least a portion of the supplemental cardiac data.

[0011] The foregoing description is not intended to depict every embodiment or every implementation of this disclosure. A more complete understanding will become apparent and readily understood by referring to the following detailed description and claims in conjunction with the accompanying drawings. Attached Figure Description

[0012] Figure 1 It is a diagram of an exemplary system that includes electrode devices, display devices, and computing devices.

[0013] Figures 2 to 3 This is a diagram of an illustrative external electrode device used to measure the surface potential of the torso.

[0014] Figure 4 This is a block diagram illustrating an exemplary method of using supplemental cardiac data to provide synchronized external electrical activity.

[0015] Figure 5 It is an exemplary graphical user interface depicting external electrical activity annotated with supplemental cardiac data.

[0016] Figure 6 This is a diagram of an exemplary system including an exemplary implantable medical device (IMD).

[0017] Figure 7A yes Figure 6 A diagram illustrating an example of an IMD.

[0018] Figure 7BIt is placed in Figure 7A A magnified view of the distal end of the electrical leads in the left ventricle.

[0019] Figure 8A For example Figures 6 to 7B A block diagram of an exemplary IMD system.

[0020] Figure 8B yes Figures 6 to 7B Another block diagram of the exemplary IMD (e.g., implantable pulse generator) circuitry and associated leads used in the system.

[0021] Detailed Implementation of the Exemplary Scheme

[0022] In the following exemplary embodiments, reference is made to the accompanying drawings, which form a part of the embodiments, and specific implementable embodiments are illustrated therein. It should be understood that other embodiments and structural changes may be utilized without departing from (e.g., still falling within) the scope of this disclosure presented herein.

[0023] Reference Figures 1 to 8B Illustrative systems and methods are described. It will be apparent to those skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes from other embodiments, and possible embodiments of such systems and methods using combinations of features set forth herein are not limited to those shown in the figures and / or the specific embodiments described herein. Furthermore, it will be appreciated that the embodiments described herein may include many elements that are not necessarily shown to scale. Even further, it will be appreciated that the timing of these processes and the size and shape of the various elements may be modified, but still fall within the scope of this disclosure, although certain timings, one or more shapes and / or sizes or types of elements may be preferred over others.

[0024] Multiple external electrodes positioned on or around the patient's surface or skin can be used to measure or monitor multiple electrocardiogram (ECG) signals (e.g., trunk surface potential). ECG signals can be used to evaluate and configure cardiac therapies, such as those provided by implantable medical devices performing cardiac resynchronization therapy (CRT), for example. As described herein, ECG signals can be collected or obtained non-invasively because, for example, implantable electrodes may not be used to measure ECG signals. Furthermore, ECG signals can be used to determine cardiac electrical activation time, which can be used to generate various metrics (e.g., electrical heterogeneity information) that a user (e.g., a physician) can use to optimize one or more settings or parameters of a cardiac therapy (e.g., pacing therapy) such as CRT.

[0025] Various exemplary systems, methods, and graphical user interfaces can be configured to use electrode devices, including external electrodes, display devices, and computing devices, to non-invasively assist users (e.g., physicians) in assessing cardiac health and / or configuring (e.g., optimizing) cardiac therapies. Figure 1 An exemplary system 100 is depicted, including an electrode device 110, a computing device 140, and a remote computing device 160.

[0026] As shown in the figure, electrode device 110 includes a plurality of electrodes incorporated or included within a band wrapped around the chest or torso of patient 14. Electrode device 110 is operatively coupled to computing device 140 (e.g., via a wired or wireless connection) to provide computing device 140 with electrical signals from each of the electrodes for analysis, evaluation, etc. An exemplary electrode device can be described in U.S. Patent No. 9,320,446, entitled “Bioelectric Sensor Device and Methods,” filed March 27, 2014, and published March 26, 2016. Further reference will be made to… Figures 2 to 3 The exemplary electrode device 110 will be described in more detail.

[0027] Although not described herein, the exemplary system 100 may further include an imaging device. The imaging device can be any type of imaging device configured to non-invasively image or provide an image of at least a portion of a patient. For example, the imaging device may provide an image of the patient without using any components or parts that may be located within the patient's body, in addition to non-invasive tools such as contrast solutions. It should be understood that the exemplary systems, methods, and interfaces described herein may further utilize the imaging device to provide non-invasive assistance to a user (e.g., a physician) to position or place one or more pacing electrodes near a patient's heart in conjunction with a cardiac therapy configuration.

[0028] For example, exemplary systems and methods may provide image-guided navigation for navigating leads, including electrodes, leadless electrodes, radio electrodes, catheters, etc., within a patient, while also providing non-invasive cardiac therapy configurations, including determining effective or optimal pre-excitation intervals, such as AV and VV intervals. Exemplary systems and methods using imaging devices and / or electrode devices are described in U.S. Patent Application Publication No. 2014 / 0371832, issued to Ghosh on December 18, 2014; U.S. Patent Application Publication No. 2014 / 0371833, issued to Ghosh et al. on December 18, 2014; U.S. Patent Application Publication No. 2014 / 0323892, issued to Ghosh et al. on October 30, 2014; and U.S. Patent Application Publication No. 2014 / 0323882, issued to Ghosh et al. on October 20, 2014.

[0029] Exemplary imaging devices can be configured to capture X-ray images and / or any other alternative imaging modalities. For example, imaging devices can be configured to capture images or image data using isocentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high-frequency ultrasound (HIFU), optical coherence tomography (OCT), intravascular ultrasound (IVUS), two-dimensional (2D) ultrasound, three-dimensional (3D) ultrasound, four-dimensional (4D) ultrasound, intraoperative CT, intraoperative MRI, etc. Furthermore, it should be understood that imaging devices can be configured to capture multiple consecutive images (e.g., sequentially) to provide video frame data. In other words, multiple images captured by the imaging device over time can provide video frame or motion picture data. Additionally, images can be acquired and displayed in two, three, or four dimensions. In more advanced forms, four-dimensional surface rendering of the heart or other areas of the body can also be achieved by combining cardiac data or other soft tissue data from mapping or preoperative image data captured from MRI, CT, or echocardiographic modalities. Image datasets from hybrid modalities (such as positron emission tomography (PET) combined with CT, or single-photon emission computed tomography (SPECT) combined with CT) can also provide functional image data overlaid on anatomical data, for example, to navigate implantable devices to target locations in the heart or other regions of interest.

[0030] Systems and / or imaging devices that can be used in conjunction with the exemplary systems and methods described herein are listed in the following U.S. Patent Application Publication No. 2005 / 0008210, issued to Evron et al., published January 13, 2005; U.S. Patent No. 2006 / 0074285, issued to Zakh et al., published April 6, 2006; U.S. Patent No. 8,731,642, issued to Zakh et al., published May 20, 2014; U.S. Patent No. 8,861,830, issued to Brada et al., published October 14, 2014; U.S. Patent No. 6,980,675, issued to Evron et al., published December 27, 2005; and U.S. Patent No. 2007 / 0008210, issued October 23, 2007. U.S. Patent No. 7,286,866 to Okerlund et al., U.S. Patent No. 7,308,297 to Reddy et al., issued December 11, 2011, U.S. Patent No. 7,308,299 to Burrell et al., issued December 11, 2011, U.S. Patent No. 7,308,299 to Burrell et al., issued January 22, 2008, U.S. Patent No. 7,321,677 to Evron et al., issued March 18, 2008, U.S. Patent No. 7,346,381 to Okerlund et al., issued March 18, 2008, U.S. Patent No. 7,454,248 to Burrell et al., issued November 18, 2008, and U.S. Patent No. 7,454,248 to Vas et al., issued March 3, 2009, U.S. Patent No. 7,286,866 to Okerlund et al., issued December 11, 2011, U.S. Patent No. 7,308,297 to Reddy et al., issued December 11, 2011, U.S. Patent No. 7,308,299 to Burrell et al., issued November 18, 2008, U.S. Patent No. 7,454,248 to Burrell et al., issued November 18, 2008, U.S. Patent No. 7,454,248 to Vas et al., issued March 3, 2009, U.S. Patent No. 7,308,297 to Burrell et al., issued December 11, 2011, U.S. Patent No. U.S. Patent No. 7,499,743 to S et al., U.S. Patent No. 7,565,190 to Okerlund et al., issued July 21, 2009, U.S. Patent No. 7,587,074 to Zakh et al., issued September 8, 2009, U.S. Patent No. 7,599,730 to Hunter et al., issued October 6, 2009, U.S. Patent No. 7,613,500 to Vass et al., issued November 3, 2009, U.S. Patent No. 7,742,629 to Zakh et al., issued June 22, 2010, and U.S. Patent No. 7,742,629 to Okerlund et al., issued June 29, 2010. U.S. Patent No. 7,778,685 to Evron et al., issued August 17, 2010; U.S. Patent No. 7,778,686 to Vass et al., issued August 17, 2010; U.S. Patent No. 7,813,785 to Okerlund et al., issued October 12, 2010; U.S. Patent No. 7,996,063 to Vass et al., issued August 9, 2011; U.S. Patent No. 8,060,185 to Hunter et al., issued November 15, 2011; and U.S. Patent No. 8,401,616 to Verard et al., issued March 19, 2013, are described in these patents.

[0031] The computing device 140 and the remote computing device 160 may each include display devices 130 and 160, respectively, which can be configured to display and analyze data, such as electrical signals (e.g., electrocardiogram data), electrical activation time, electrical heterogeneity information, etc. For example, one cardiac cycle or heartbeat from multiple cardiac cycles or heartbeats represented by electrical signals collected or monitored by the electrode device 110 can be analyzed and evaluated for one or more measures, including activation time and electrical heterogeneity information, which may be related to the therapeutic nature of one or more parameters such as pacing parameters, lead positions, etc., relevant to cardiac therapy. More specifically, for example, the QRS complex of a single cardiac cycle can be assessed for one or more measures, such as, for example, QRS onset, QRS deviation, QRS peak, electrical heterogeneity information (EHI), electrical activation time with reference to the earliest activation time, standard deviation of left ventricular or chest electrical activation time (LVED), standard deviation of activation time (SDAT), mean left ventricular or chest substitution electrical activation time (LVAT), QRS duration (e.g., the interval between QRS onset and QRS deviation), the difference between mean left substitution and mean right substitution activation times, relative or absolute QRS morphology, the difference between the higher and lower percentiles of activation time (the higher percentile could be 90%, 80%, 75%, 70%, etc., and the lower percentile could be 10%, 15%, 20%, 25%, and 30%, etc.), other statistical measures of central tendency (e.g., median or mode), dispersion (e.g., mean deviation, standard deviation, variance, interquartile range), etc. Furthermore, each of these one or more measurements can be location-specific. For example, some measurements can be estimated based on signals recorded or monitored from electrodes positioned around selected areas of the patient (such as, for example, the patient's left side, the patient's right side, etc.).

[0032] In at least one embodiment, one or both of the computing device 140 and the remote computing device 160 may be a server, a personal computer, or a tablet computer. The computing device 140 may be configured to receive input from an input device 142 (e.g., a keyboard) and transmit output to a display device 130, and the remote computing device 160 may be configured to receive input from an input device 162 (e.g., a touchscreen) and transmit output to a display device 170. One or both of the computing device 140 and the remote computing device 160 may include a data storage device that allows access to processing programs or routines and / or one or more other types of data, such as for analyzing multiple electrical signals captured by the electrode device 110, for determining QRS initiation, QRS offset, median, mode, average, peak or maximum, trough or minimum, for determining electrical activation time, and for driving a graphical user interface configured to non-invasively assist the user in configuring one or more pacing parameters or settings, such as, for example, pacing rate, ventricular pacing rate, AV interval, VV interval, pacing pulse width, pacing vector, multi-point pacing vector (e.g., left ventricular vector four-lead), pacing voltage, pacing configuration (e.g., biventricular pacing, right ventricular pacing only, left ventricular pacing only, etc.), as well as arrhythmia detection and treatment, rate adaptive settings, and performance, etc.

[0033] Computing device 140 is operatively coupled to input device 142 and display device 130 to, for example, transmit data to and from each of input device 142 and display device 130, and remote computing device 160 is operatively coupled to input device 162 and display device 170 to, for example, transmit data to and from each of input device 162 and display device 170. For example, computing device 140 and remote computing device 160 may be electrically coupled to input devices 142, 162 and display devices 130, 170 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, Internet-based connections, etc. As further described herein, a user may provide input to input devices 142, 162 to view and / or select one or more configuration information related to cardiac therapy delivered by a cardiac therapy device (such as, for example, an implantable medical device).

[0034] Each of the remote computing device 160 and computing device 140 may include a communication interface. The communication interfaces of the remote computing device 160 and computing device 140 can be used to communicate with other devices and equipment, such as electrode device 110, and with each other. As will be further described herein, the communication interface can be used to acquire supplemental cardiac data from multiple different implantable or external medical devices. In one embodiment, the communication interface may include a transceiver and an antenna for wireless communication with external devices using radio frequency (RF) communication or other communication protocols. Furthermore, the communication interface may be configured to be unidirectional or bidirectional.

[0035] Although input device 142 is a keyboard and input device 162 is a touchscreen as depicted, it should be understood that input devices 142 and 162 may include any device capable of providing input to computing device 140 and computing device 160 for performing the functions, methods, and / or logic described herein. For example, input devices 142 and 162 may include a keyboard, mouse, trackball, touchscreen (e.g., capacitive touchscreen, resistive touchscreen, multi-touch touchscreen, etc.), etc. Similarly, display devices 130 and 170 may include any device capable of displaying information to a user, such as graphical user interfaces 132 and 172. This information includes electrode status information, graphical representations of electrical activation, multiple signals from external electrodes over one or more heartbeats, QRS complexes, selection areas for various cardiac therapy options, rankings of various cardiac therapy options, various pacing parameters, electrical heterogeneity information (EHI), text descriptions, graphical descriptions of human cardiac anatomy, images or graphical descriptions of a patient's heart, graphical depictions of the human torso, images or graphical depictions of the patient's torso, images or graphical depictions of the human torso, graphical depictions or actual images of implanted electrodes and / or leads, etc. Furthermore, display devices 130 and 170 may include liquid crystal displays, organic light-emitting diode screens, touchscreens, cathode ray tube displays, etc.

[0036] The processing programs or routines stored and / or executed by the computing device 140 and the remote computing device 160 may include computational mathematics programs or routines, matrix mathematics, decomposition algorithms, compression algorithms (e.g., data compression algorithms), calibration algorithms, image construction algorithms, signal processing algorithms (e.g., various filtering algorithms, Fourier transform, fast Fourier transform, etc.), normalization algorithms, comparison algorithms, vector mathematics, or any other processing for implementing one or more exemplary methods and / or processes described herein. Data stored and / or used by computing device 140 and remote computing device 160 may include, for example, electrical signal / waveform data (e.g., multiple QRS complex waves) from electrode device 110, electrical activation time from electrode device 110, heart sound / signal / waveform data from acoustic sensor, graphics (e.g., graphic elements, icons, buttons, windows, dialog boxes, drop-down menus, graphic areas, graphic regions, 3D graphics, etc.), graphical user interfaces, results from one or more processing procedures or routines employed in accordance with the disclosure herein (e.g., electrical signals, electrical heterogeneity information, etc.), or any other data used to perform one or more processes or methods described herein.

[0037] In one or more embodiments, these exemplary systems, methods, and interfaces may be implemented using one or more computer programs that execute on a programmable computer, such as a computer including, for example, processing power, data storage devices (e.g., volatile or non-volatile memory and / or storage elements), input devices, and output devices. The program code and / or logic described herein may be applied to input data to perform the functions described herein and generate desired output information. The output information may be applied as input to one or more other means and / or methods, as described herein or applied in a known manner.

[0038] The one or more programs used to implement the systems, methods, and / or interfaces described herein may be provided using any programmable language, such as high-level programming and / or object-oriented programming languages ​​suitable for communicating with computer systems. Any such program may be stored, for example, on any suitable means, such as a storage medium, which may be readable by a general-purpose or special-purpose program running on a computer system (e.g., including a processing device) for configuring and operating the computer system when the suitable means are read to execute the program described herein. In other words, at least in one embodiment, these exemplary systems, methods, and interfaces may be implemented using a computer-readable storage medium configured with a computer program, wherein the storage medium is configured to cause a computer to operate in a specific and predefined manner to perform the functions described herein. Further, in at least one embodiment, these exemplary systems, methods, and interfaces may be described as being implemented by logic (e.g., object code) encoded in one or more non-transitory media including code for execution, and operable when executed by a processor or processing circuitry to perform operations such as methods, processes, and / or functions as described herein.

[0039] The computing device 140 and the remote computing device 160 can be, for example, any fixed or mobile computer system (e.g., a controller, microcontroller, personal computer, microcomputer, tablet computer, etc.). The exact configuration of the computing device 140 and the remote computing device 160 is not limiting and can essentially be any device capable of providing suitable computing and control capabilities (e.g., signal analysis, mathematical functions such as median, mode, average, maximum value determination, minimum value determination, slope determination, minimum slope determination, maximum slope determination, graphics processing, etc.). As described herein, a digital file can be any medium (e.g., volatile or non-volatile memory, CD-ROM, punched card, magnetically recordable tape, etc.) containing digital bits (e.g., encoded in binary, ternary, etc.) that can be read and / or written by the computing device 140 and the remote computing device 160 described herein. Furthermore, as described herein, a user-readable format file can be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphics, etc.) that can be presented on any medium that is readable and / or understandable to a user. Each of the remote computing device 140 and the local computing device may include a communication interface. The communication interface of the remote computing device 140 may be referred to as a remote communication interface, and the communication interface of the local computing device 160 may be referred to as a local communication interface. The communication interfaces of the remote computing device 160 and the computing device 140 can be used to communicate with other devices and equipment such as electrode device 110, any other medical devices that may include supplemental cardiac data, and with each other. In one embodiment, the communication interface may include a transceiver and an antenna for wireless communication with external devices using radio frequency (RF) communication or other communication protocols. Furthermore, the communication interface may be configured to be unidirectional or bidirectional.

[0040] In view of the foregoing, it will be apparent that the functions described in one or more embodiments according to this disclosure can be implemented in any manner known to those skilled in the art. Therefore, computer languages, computer systems, or any other software / hardware intended for implementing the processes described herein should not limit the scope of the systems, processes, or programs described herein (e.g., the functions provided by such systems, processes, or programs).

[0041] The exemplary electrode device 110 can be configured to measure the body surface potential of the patient 14, and more specifically, to measure the trunk surface potential of the patient 14. Figure 2As shown, the exemplary electrode device 110 may include a set of external electrodes or an array of external electrodes 112, a strip 113, and an interface / amplifier circuitry 116. Electrodes 112 may be attached to or coupled to the strip 113, and the strip 113 may be configured to wrap around the torso of the patient 14 such that the electrodes 112 surround the patient's heart. As further illustrated, the electrodes 112 may be positioned around the circumference of the patient 14, including posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0042] The exemplary electrode device 110 may be further configured to measure or monitor at least one or both of the sounds from the patient 14. For example... Figure 2 As shown, the exemplary electrode device 110 may include a set of acoustic sensors or an array of acoustic sensors 120 attached to or coupled to the strip 113. The strip 113 may be configured to wrap around the torso of the patient 14 such that the acoustic sensors 120 surround the patient's heart. As further illustrated, the acoustic sensors 120 may be positioned around the circumference of the patient 14, including posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0043] Furthermore, electrode 112 and acoustic sensor 120 can be electrically connected to interface / amplifier circuitry 116 via wired connection 118. Interface / amplifier circuitry system 116 can be configured to amplify signals from electrode 112 and acoustic sensor 120 and provide these signals to one or both of computing device 140 and remote computing device 160. Other exemplary systems may use wireless connections to transmit signals sensed by electrode 112 and acoustic sensor 120 to interface / amplifier circuitry 116, and subsequently to one or both of computing device 140 and remote computing device 160, for example, as a data channel. In one or more embodiments, interface / amplifier circuitry 116 may be electrically coupled to computing device 140 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, internet-based connections, etc.

[0044] Despite Figure 2In one example, electrode device 110 includes a strip 113; however, in other examples, any of a variety of mechanisms (e.g., tape or adhesive) may be used to aid in the spacing and placement of electrodes 112 and acoustic sensors 120. In some examples, strip 113 may comprise elastic bands, tape strips, or fabric. Further, in some examples, strip 113 may be part of or integrated with a garment (such as, for example, a T-shirt). In other examples, electrodes 112 and acoustic sensors 120 may be placed separately on the torso of patient 14. Further, in other examples, one or both of electrodes 112 (e.g., arranged in an array) and acoustic sensors 120 (e.g., also arranged in an array) may be part of or located within a patch, vest, and / or other means of securing electrodes 112 and acoustic sensors 120 to the torso of patient 14. Still further, in other examples, one or both of electrodes 112 and acoustic sensors 120 may be part of or located within two material portions or two patches. One of the two patches may be located on the anterior side of the patient 14's torso (e.g., to monitor electrical signals representing the anterior side of the patient's heart, measure the electrical activation time of an alternative heart representing the anterior side of the patient's heart, monitor or measure sound on the anterior side of the patient, etc.), and the other patch may be located on the posterior side of the patient 14's torso (e.g., to monitor electrical signals representing the posterior side of the patient's heart, measure the electrical activation time of an alternative heart representing the posterior side of the patient's heart, monitor or measure sound on the posterior side of the patient, etc.). Furthermore, in other examples, one or both of the electrode 112 and the acoustic sensor 120 may be arranged in top and bottom rows extending from the anterior side of the patient 14, across the left side of the patient 14, to the posterior side of the patient 14. Furthermore, in other examples, one or both of the electrode 112 and the acoustic sensor 120 may be arranged in a curve around the axillary region, and the electrode / sensor density on the right chest may be lower than the density in other remaining areas.

[0045] Electrode 112 can be configured to surround the heart of patient 14 and to record or monitor electrical signals associated with cardiac depolarization and repolarization after a signal has propagated through the torso of patient 14. Each of electrode 112 can be used in a unipolar configuration to sense torso surface potentials reflecting cardiac signals. Interface / amplifier circuitry 116 can also be coupled to a return electrode or an unrelated electrode (not shown) that can be combined with each electrode 112 for unipolar sensing.

[0046] In some examples, approximately 12 to approximately 50 electrodes 112 and approximately 12 to approximately 50 acoustic sensors 120 may be spatially distributed around the patient's torso. Other configurations may have more or fewer electrodes 112 and more or fewer acoustic sensors 120. It should be understood that the electrodes 112 and acoustic sensors 120 may not be arranged or may be distributed in an array that extends all the way around or completely around the patient 14. Instead, the electrodes 112 and acoustic sensors 120 may be arranged in an array that extends only around a portion or partially around the patient 14. For example, the electrodes 112 and acoustic sensors 120 may be distributed on the front, back, and left sides of the patient, with fewer or no electrodes and acoustic sensors near the right side (including the posterior and anterior regions of the patient's right side).

[0047] The computing device 140 can record and analyze trunk surface potential signals sensed by electrode 112 and sound signals sensed by acoustic sensor 120, which are amplified / modulated by interface / amplifier circuitry 116. The computing device 140 can be configured to analyze electrical signals from electrode 112 to provide electrocardiogram (ECG) signals, information, or data from the patient's heart, as will be further described herein. The computing device 140 can be configured to analyze electrical signals from acoustic sensor 120 to provide sound signals, information, or data from devices within and / or implanted in the patient, such as left ventricular assist devices.

[0048] Additionally, computing device 140 and telecomputing device 160 may be configured to provide graphical user interfaces 132, 172 depicting various information associated with electrode device 110 and data collected or sensed using electrode device 110. For example, graphical user interfaces 132, 172 may depict ECG data including QRS complexes obtained using electrode device 110 and acoustic data including acoustic waves obtained using acoustic sensor 120, along with other related information. Exemplary systems and methods may non-invasively use electrical information collected using electrode device 110 and acoustic information collected using acoustic sensor 120 to assess a patient's cardiac health and evaluate and configure cardiac therapies being delivered to the patient.

[0049] Furthermore, the electrode device 110 may further include reference electrodes and / or drive electrodes, which will be positioned, for example, around the lower torso of the patient 14, and the system 100 may further use these reference electrodes and / or drive electrodes. For example, the electrode device 110 may include three reference electrodes, and signals from the three reference electrodes may be combined to provide a reference signal. Furthermore, the electrode device 110 may use three tail reference electrodes (e.g., instead of the standard reference used in Wilson central terminals) to obtain a “true” unipolar signal with less noise by averaging the reference signals from the three tail-positioned electrodes.

[0050] Figure 3 Another exemplary electrode device 110 is shown, comprising a plurality of electrodes 112 configured to surround the heart of a patient 14 and to record or monitor electrical signals associated with depolarization and repolarization of the heart after the signal has propagated through the torso of the patient 14, and a plurality of acoustic sensors 120 configured to surround the heart of the patient 14 and to record or monitor acoustic signals associated with the heart after the signal has propagated through the torso of the patient 14. The electrode device 110 may include a vest 114 to which the plurality of electrodes 112 and the plurality of acoustic sensors 120 may be attached, or the electrodes 112 and the acoustic sensors 120 may be coupled to the vest. In at least one embodiment, the plurality of electrodes 112 or electrode array may be used to collect electrical information, such as, for example, alternative electrical activation time. Similar to... Figure 2 Electrode equipment 110, Figure 3 The electrode device 110 may include an interface / amplifier circuit 116 electrically coupled to each of the electrodes 112 and the acoustic sensor 120 via a wired connection 118 and configured to transmit signals from the electrodes 112 and the acoustic sensor 120 to the computing device 140. As shown in the figure, the electrodes 112 and the acoustic sensor 120 may be distributed on the torso of the patient 14, including, for example, posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0051] Vest 114 may be formed of fabric, to which electrodes 112 and acoustic sensors 120 are attached. Vest 114 may be configured to maintain the positioning and spacing of electrodes 112 and acoustic sensors 120 on the torso of patient 14. Further, vest 114 may be marked to aid in determining the position of electrodes 112 and acoustic sensors 120 on the surface of patient 14's torso. In some examples, approximately 25 to approximately 256 electrodes 112 and approximately 25 to approximately 256 acoustic sensors 120 may be distributed around the torso of patient 14, but other configurations may have more or fewer electrodes 112 and more or fewer acoustic sensors 120.

[0052] Furthermore, it should be understood that computing device 140, remote computing device 160, and any other devices described herein can be operatively coupled to each other in a variety of different ways to perform or execute the functions described herein. For example, in the illustrated embodiment, computing device 140, remote computing device 160, and another device or multiple devices that can provide supplemental cardiac data can be wirelessly operatively coupled to each other, such as... Figure 1 The wireless signal lines emanating between them are depicted. In addition, in contrast to the wireless connection, one or more of the computing device 140, the remote computing device 160, and other devices that can provide supplemental cardiac data can be operatively coupled to each other via a single or wired electrical connection.

[0053] These exemplary systems and methods can be used to provide non-invasive assistance to users (e.g., via implantable medical devices, via LVADs, etc.) when assessing a patient’s cardiac health and / or evaluating and configuring cardiac therapies currently being delivered to the patient. For example, these exemplary systems and methods can be used to assist users in configuring and / or adjusting one or more cardiac therapy settings, such as optimizing the AV interval or delay of pacing therapies (e.g., left ventricle only or left univentricular pacing therapy) and the AV interval or delay and VV interval and delay of pacing therapies (e.g., biventricular pacing therapy).

[0054] Figure 4 An exemplary method 200 for providing synchronized external electrical activity using supplemental cardiac data is described. The exemplary method 200 can be broadly described as correlating electrical activity monitored by multiple external electrodes from a patient's skin with supplemental cardiac data provided by any other device configured to collect cardiac data from the patient.

[0055] An exemplary method 200 may include using multiple external electrodes 202 to monitor or measure electrical activity. (See the section on...) Figures 1 to 3 The plurality of external electrodes may be similar to the external electrodes provided by electrode device 110. For example, the plurality of external electrodes may be part of or incorporated into a vest or band located around the patient's torso. More specifically, the plurality of electrodes may be described as surface electrodes positioned in an array and configured to be located near the skin of the patient's torso. The electrical activity monitored during process 202 prior to the delivery of cardiac therapy may be referred to as "baseline" electrical activity because no therapy is delivered to the patient, causing the patient's heart to be in its natural or inherent rhythm.

[0056] Method 200 may further include receiving supplemental cardiac data 204. The supplemental cardiac data may include any data other than electrical activity monitored by multiple external electrodes related to the patient's heart. For example, the supplemental cardiac data may include various signals representing data over time, such as internal cardiac electrical signals provided by a left ventricular assist device (e.g., measured under the patient's skin), heart sounds, cardiac pressure, blood flow, estimated instantaneous flow waveforms, etc.

[0057] Furthermore, for example, supplemental cardiac data may include various markers indicating the occurrence of cardiac events. More specifically, such markers may include markers indicating intrinsic atrial depolarization, atrial pacing, atrial premature beat complexes, intrinsic ventricular depolarization, ventricular pacing, ventricular premature beat complexes, ventricular repolarization during intrinsic or pacing ventricular events, effective ventricular or atrial capture, ineffective ventricular or atrial capture, valvular closure, valvular opening, systole, and diastole.

[0058] Supplemental cardiac data can be acquired from multiple different implantable or external sources. For example, supplemental cardiac data can be acquired from implantable medical devices. Furthermore, for example, supplemental cardiac data can be acquired from an external array of acoustic sensors, such as those described herein. Figures 1 to 3 The electrode device 110 is shown. Furthermore, supplemental cardiac data can be obtained, for example, from cardiac pacemakers, left ventricular assist devices, cardioverter defibrillators, subcutaneous monitoring devices, and intracardiac pressure sensors.

[0059] Once electrical activity 202 has been detected and supplemental cardiac data 204 has been received, method 200 may include synchronizing the detected electrical activity and supplemental cardiac data 206. For example, each of the detected electrical activity and supplemental cardiac data may have associated time information (e.g., a timestamp). In other words, a clock may “keep track” the data relative to time while the detected electrical activity and supplemental cardiac data are being collected. The time information of the detected electrical activity and the time information of the supplemental cardiac data may be concatenated to synchronize the detected electrical activity and supplemental cardiac data. Further, for example, each of the electrode device / computing device and the device providing the supplemental cardiac data may include a clock to be synchronized such that when the device sends tagging information along with a clock cycle or timestamp measured by the implanted device, the electrode device / computing device can receive and place the tagging signal at the appropriate time relative to its own clock and its own data. Further still, for example, synchronization between the electrode device / computing device and the device providing the supplemental cardiac data may be performed by matching the clock times of the devices and apparatus to each other or calibrating them to a time server. In at least one embodiment, such synchronization may be performed using cloud-based technologies.

[0060] After the monitored electrical activity and supplemental cardiac data have been synchronized or connected, method 200 may utilize such synchronization or connection to perform various processes to enhance the monitored electrical activity, to display the synchronized cardiac data, and to generate one or more measures relative to the synchronized cardiac data.

[0061] For example, method 200 may include modifying the monitored electrical activity based on synchronous supplemental cardiac data 208. For example, the electrical activity monitored using the multiple external electrodes can be used for further analysis. However, the monitored electrical activity may be negatively affected by various cardiac events, such as pacing pulses from an implanted pacemaker. Therefore, in one or more embodiments, the monitored electrical activity may be ignored for a selected time period following ventricular pacing indicated by the supplemental cardiac data. In this way, ventricular pacing may not negatively affect the monitored electrical activity used for analysis. The selected time period may be between approximately 1 millisecond (ms) and 20 ms. In at least one embodiment, the selected time period is 5 ms. The selected time period may be referred to as the blanking period. In other words, the supplemental cardiac data can be used to filter or “clean up” the monitored electrical activity.

[0062] After modifying the monitored electrical activity, method 200 may further generate electrical heterogeneity information (EHI) 210 based on the modified monitored electrical activity. EHI may be described as information or data representing at least one of mechanical cardiac function and electrical cardiac function. EHI and other cardiac therapy information may be described in U.S. Provisional Patent Application No. 61 / 834,133, filed June 12, 2013, entitled “METRICS OF ELECTRICAL DISYSSYNCHRONY AND ELECTRICAL ACTIVATION PATTERNS FROM SURFACE ECG ELECTRODES,” which is incorporated herein by reference in its entirety.

[0063] Electrical heterogeneity information (e.g., data) can be defined as information indicating at least one of mechanical or asynchronicity of the heart and / or electrical or asynchronicity of the heart. In other words, electrical heterogeneity information can represent an alternative to the actual mechanical and / or electrical function of the patient's heart. In at least one embodiment, relative changes in electrical heterogeneity information (e.g., from baseline heterogeneity information to therapeutic heterogeneity information, from a first set of heterogeneity information to a second set of therapeutic heterogeneity information, etc.) can be used to determine alternative values ​​representing changes in hemodynamic response (e.g., acute changes in the LV pressure gradient). Left ventricular pressure can typically be invasively monitored using a pressure sensor located in the left ventricle of the patient's heart. Therefore, using electrical heterogeneity information to determine alternative values ​​representing left ventricular pressure avoids the invasive monitoring required by left ventricular pressure sensors.

[0064] In at least one embodiment, electrical heterogeneity information may include the standard deviation of ventricular activation time measured using some or all of the external electrodes, such as those in electrode device 110. Further, local or regional electrical heterogeneity information may include the standard deviation and / or mean of activation time measured using electrodes located in certain anatomical regions of the trunk. For example, external electrodes on the left side of the patient's trunk may be used to calculate local or regional left-sided electrical heterogeneity information.

[0065] Electrical heterogeneity information can be generated using one or more different systems and / or methods. For example, electrical heterogeneity information can be generated using surface electrode arrays or multiple surface electrodes and / or imaging systems as described in the following U.S. patents: U.S. Patent Application Publication No. 2012 / 0283587A1, published November 8, 2012, entitled “ASSESSING INTRA-CARDIAC ACTIVATION PATTERNS AND ELECTRICAL DYSSYNCHRONY”; U.S. Patent Application Publication No. 2012 / 0284003A1, published November 8, 2012, entitled “ASSESSING INTRA-CARDIAC ACTIVATION PATTERNS”; and U.S. Patent No. 8,180,428B2, published May 15, 2012, entitled “METHODS AND SYSTEMS FOR USEIN SELECTING CARDIAC PACING SITES”.

[0066] Information on electrical heterogeneity may include one or more measures or indices. For example, one measure or index of electrical heterogeneity may be the standard deviation of activation time (SDAT) measured using some or all electrodes on the surface of a patient's torso. In some examples, the SDAT may be calculated using estimated cardiac activation time on the surface of a model heart.

[0067] Another measure or index of electrical heterogeneity may be the left standard deviation (LVED) of the surrogate electrical activation time monitored by external electrodes located near the patient's left side. Further, another measure or index of electrical heterogeneity may include the mean (LVAT) of the surrogate electrical activation time monitored by external electrodes located near the patient's left side. LVED and LVAT may be determined (e.g., calculated, estimated, etc.) based solely on electrical activity measured by electrodes located only near the patient's left side, which may be referred to as "left" electrodes. The left electrode may be defined as any surface electrode located near the left ventricle, which includes the region on the left side of the patient's sternum and spine. In one embodiment, the left electrode may include all anterior electrodes on the left side of the sternum and all posterior electrodes on the left side of the spine. In another embodiment, the left electrode may include all anterior electrodes on the left side of the sternum and all posterior electrodes. In yet another embodiment, the left electrode may be designated based on the contours of the left and right sides of the heart determined using imaging equipment such as X-rays, fluoroscopy, etc.

[0068] Another exemplary measure or index of asynchrony can be the range of activation time (RAT), which can be estimated as the difference between the maximum and minimum activation times on the trunk surface or heart, for example, overall or for a region. RAT reflects the span of activation time, while SDAT gives an estimate of the dispersion of activation time from the mean. SDAT also provides an estimate of the heterogeneity of activation time, because if activation time is spatially heterogeneous, individual activation times will deviate from the mean activation time, thus indicating that one or more cardiac regions have been delayed in activation. In some examples, the estimated cardiac activation times on the surface of a model heart can be used to calculate RAT.

[0069] Another exemplary measure or index of electrical heterogeneity information may include an estimate of the percentage of surface electrodes located in a specific region of interest in the trunk or heart where the associated activation time is greater than a certain percentile, such as the 70th percentile of the measured QRS complex duration or the determined activation time of the surface electrode. The region of interest may be, for example, the posterior region, the left anterior region, and / or the left ventricular region. An exemplary measure or index may be referred to as the percentage of delayed activation (PLAT). PLAT can be described as providing an estimate of the percentage of the region of interest, such as the posterior and left anterior regions of the heart associated with the left ventricular region, which are later activated. A large PLAT value may indicate delayed activation of a large portion of that region (e.g., the left ventricle) and the potential benefit of electrical resynchronization via CRT through pre-excitation (e.g., of the late region of the left ventricle). In other examples, PLAT may be determined for other regions, such as additional subsets of electrodes in the right anterior region, to assess delayed activation in the right ventricle. In addition, in some examples, the estimated cardiac activation time on the surface of the model heart can be used to calculate PLAT for the whole heart or a specific region of the heart (e.g., the left or right ventricle).

[0070] In one or more embodiments, electrical heterogeneity information may include indicators of favorable changes in global cardiac electrical activation, such as those described, for example, in the following literature: Sweeney et al., “Analysis of Ventricular Activation Using Surface Electrocardiography to Predict Left Ventricular Reverse Volumetric Remodeling During Cardiac Resynchronization Therapy”, Circulation, February 9, 2010, Vol. 121, No. 5, pp. 626-634; and / or Van Deursen et al., “Vectorcardiography as a Tool for Easy Optimization of Cardiac Resynchronization Therapy in Canine LBBB Hearts”, Circulation Arrhythmia and Electrophysiology, June 1, 2012, Vol. 5, No. 3, pp. 544-552.

[0071] Heterogeneity information may also include measurements of improved cardiac mechanical function, measured by imaging or other systems, to track the motion of implanted leads within the heart, for example, as described in the following literature: Ryu et al., “Simultaneous Electrical and Mechanical Mapping Using 3DCardiac Mapping System: Novel Approach for Optimal Cardiac Resynchronization Therapy,” Journal of Cardiovascular Electrophysiology, February 2010, Vol. 21, No. 2, pp. 219-222; Sperzel et al., “Intraoperative Characterization of Interventricular Mechanical Dyssynchrony Using Electroanatomic Mapping System—A Feasibility Study,” Journal of Interventional Cardiac Electrophysiology, November 2012, Vol. 35, No. 2, pp. 189-196; and / or entitled “METHOD FOR OPTIMIZAING CRT”. THERAPY” and its U.S. patent application publication number 2009 / 0099619A1, filed on April 16, 2009.

[0072] Furthermore, method 200 may include displaying the monitored electrical activity 212 and annotating the displayed monitored electrical activity 214 with synchronous supplemental cardiac data. Figure 5 An exemplary graphical user interface 250 is shown, depicting monitored external electrical activity 260 annotated with supplemental cardiac data.

[0073] Figure 5The graphical user interface 250 depicts multiple external electrical signals 260 plotted over five heartbeats or cardiac cycles. Various markers from supplemental cardiac data are annotated with respect to the electrical signals. For example, a pacing atrial marker 270 (one of which is marked) indicating when atrial pacing occurs is represented by a solid diamond. Further, for example, a ventricular capture indicator 272 (one of which is marked) is located near the electrical signal 260 for each cardiac cycle, with the letter "E" in a box indicating a valid ventricular capture or the letter "I" in a box indicating an invalid ventricular capture. Further still, for example, a pacing ventricle marker 274 (one of which is marked) indicating when left ventricular pacing occurs is represented by a solid box. And further still, for example, a QRS initiation and QRS offset indicator 276 (one of which is marked) indicating when QRS initiation and offset occur is represented by a solid vertical line.

[0074] Although only Figure 5 Several supplementary cardiac data points are annotated on the monitored electrical activity shown on the graphical user interface 250; however, it should be understood that any of the supplementary cardiac data described herein can be annotated or added to the monitored electrical activity on the graphical user interface 250. Additionally, the exemplary systems and methods described herein may allow users to manually annotate the monitored electrical activity and any other supplementary cardiac data on the graphical user interface. For example, a user may manually annotate ventricular events on the monitored electrical activity. Furthermore, these exemplary systems and methods can configure various cardiac therapy device parameters based at least in part on the displayed monitored electrical activity, the generated EHI, and the supplementary cardiac data. In other words, all traces and annotations depicted on the graphical user interface can be evaluated to make decisions regarding the final device parameters.

[0075] Method 200 may further include generating one or more measures 216 using data from both the monitored electrical activity and supplemental cardiac data. For example, at least one interval may be generated between a first event indicated by the monitored electrical activity and a second event indicated by the supplemental cardiac data. Examples of such intervals may be inter-chamber intervals, such as the interval between an atrial event and the next ventricular event, or the interval between two consecutive events within the same chamber, such as, for example, an atrial-to-interventricular interval or a ventricular-to-ventricular interval that provides the length of an atrial or ventricular cycle.

[0076] Illustrative cardiac therapy systems and devices may be referenced. Figures 6 to 8B As further described in this paper, it can utilize the paper's relative... Figures 1 to 5 Describe exemplary systems, interfaces, methods, and processes. For example, Figures 6 to 8B The therapeutic system 10 described herein can be configured to provide supplemental cardiac data to exemplary systems and methods for use in synchronization with monitored electrical activity.

[0077] Figure 6This is a conceptual diagram illustrating an exemplary therapy system 10 that can be used to deliver pacing therapy to a patient 14. The patient 14 may be, but is not necessarily, a person. The therapy system 10 may include an implantable medical device 16 (IMD) that can be coupled to leads 18, 20, 22. The IMD 16 may be, for example, an implantable pacemaker, cardioverter-defibrillator, and / or a defibrillator that delivers or provides electrical signals (e.g., pacing, etc.) to the heart 12 of the patient 14 and / or senses electrical signals from the heart via electrodes coupled to one or more of leads 18, 20, 22.

[0078] Leads 18, 20, and 22 extend into the heart 12 of the patient 14 to sense the electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12. Figure 6 In the example shown, right ventricle (RV) lead 18 extends through one or more veins (not shown), the superior vena cava (not shown), and the right atrium 26, and enters right ventricle 28. Left ventricle (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, and the right atrium 26, and enters coronary sinus 30 to reach the region adjacent to the free wall of the left ventricle 32 of heart 12. Right atrium (RA) lead 22 extends through one or more veins and the vena cava, and enters right atrium 26 of heart 12.

[0079] The IMD 16 can sense electrical signals, such as those associated with depolarization and repolarization of the heart 12, via electrodes coupled to at least one of leads 18, 20, and 22. In some examples, the IMD 16 delivers pacing therapy (e.g., pacing pulses) to the heart 12 based on electrical signals sensed within the heart 12. The IMD 16 is operable to adjust one or more parameters associated with the pacing therapy, such as, for example, AV delay and various other timing, pulse width, amplitude, voltage, burst length, etc. Furthermore, the IMD 16 is operable to deliver pacing therapy using various electrode configurations, which may be unipolar, bipolar, quadripolar, or further multipolar. For example, a multipolar lead may include several electrodes that can be used to deliver pacing therapy. Thus, a multipolar lead system can provide or supply multiple electrical vectors for pacing from them. A pacing vector may include at least one cathode and at least one anode, the at least one cathode being at least one electrode located on at least one lead, and the at least one anode being at least one electrode located on at least one lead (e.g., the same lead or different leads) and / or on the housing or canister of the IMD. While the improvement in cardiac function from pacing therapy may depend primarily on the cathode, electrical parameters such as impedance, pacing threshold voltage, current consumption, and shelf life may depend more on the pacing vector, including both the cathode and anode. The IMD 16 can also deliver defibrillation and / or cardioversion therapy via electrodes located on at least one of leads 18, 20, and 22. Furthermore, the IMD 16 can detect arrhythmias of heart 12, such as fibrillation in ventricles 28 and 32, and deliver defibrillation therapy to heart 12 in the form of electrical pulses. In some examples, the IMD 16 can be programmed to deliver a therapy process (e.g., pulses with increasing energy levels) until fibrillation in heart 12 ceases.

[0080] Figures 7A to 7B To show in more detail Figure 6 A conceptual diagram of the IMD 16 and leads 18, 20, 22 of the therapy system 10. Leads 18, 20, 22 may be electrically coupled via connector block 34 to a therapy delivery module (e.g., for delivering pacing therapy), a sensing module (e.g., for sensing one or more signals from one or more electrodes), and / or any other module of the IMD 16. In some examples, the proximal ends of leads 18, 20, 22 may include electrical contacts electrically coupled to corresponding electrical contacts within connector block 34 of the IMD 16. Additionally, in some examples, leads 18, 20, 22 may be mechanically coupled to connector block 34 by means of a retaining screw, connecting pin, or another suitable mechanical coupling mechanism.

[0081] Each of leads 18, 20, and 22 includes an elongated insulated lead that can carry multiple conductors (e.g., concentric coil conductors, straight conductors, etc.) separated from each other by insulation (e.g., a tubular insulating sheath). In the illustrated example, bipolar electrodes 40 and 42 are located near the distal end of lead 18. Additionally, bipolar electrodes 44, 45, 46, and 47 are located near the distal end of lead 20, and bipolar electrodes 48 and 50 are located near the distal end of lead 22.

[0082] Electrodes 40, 44, 45, 46, 47, and 48 may be in the form of ring electrodes, and electrodes 42 and 50 may be in the form of extendable spiral-tipped electrodes retractably mounted within insulated electrode heads 52, 54, and 56, respectively. Each of electrodes 40, 42, 44, 45, 46, 47, 48, and 50 may be electrically coupled to a corresponding conductor (e.g., coiled and / or straight) within the conductor body of its associated leads 18, 20, and 22, and thereby coupled to a corresponding electrical contact in an electrical contact at the proximal end of leads 18, 20, and 22.

[0083] Additionally, electrodes 44, 45, 46, and 47 may have a diameter of approximately 5.3 mm. 2 Approximately 5.8mm 2 The electrode surface area. Electrodes 44, 45, 46, and 47 may also be referred to as LV1, LV2, LV3, and LV4, respectively. The LV electrodes on lead 20 (i.e., left ventricular electrode 1 (LV1) 44, left ventricular electrode 2 (LV2) 45, left ventricular electrode 3 (LV3) 46, and left ventricular electrode 4 (LV4) 47, etc.) can be spaced at variable distances. For example, electrode 44 may be spaced from electrode 45 by, for example, about 21 mm, electrodes 45 and 46 may be spaced apart from each other by, for example, about 1.3 mm to about 1.5 mm, and electrodes 46 and 47 may be spaced apart from each other by, for example, about 20 mm to about 21 mm.

[0084] Electrodes 40, 42, 44, 45, 46, 47, 48, and 50 can be further used to sense electrical signals (e.g., morphological waveforms within an electrogram (EGM)) accompanying depolarization and repolarization of the heart 12. The electrical signals are conducted to the IMD 16 via corresponding leads 18, 20, and 22. In some examples, the IMD 16 can also deliver pacing pulses via electrodes 40, 42, 44, 45, 46, 47, 48, and 50 to induce depolarization of the cardiac tissue of the patient's heart 12. In some examples, such as... Figure 7AAs shown, the IMD 16 includes one or more housing electrodes, such as housing electrode 58, which may be integrally formed with or otherwise coupled to the outer surface of the housing 60 (e.g., a hermetically sealed housing) of the IMD 16. Any of electrodes 40, 42, 44, 45, 46, 47, 48, and 50 may be combined with housing electrode 58 for unipolar sensing or pacing. Those skilled in the art will understand that other electrodes may also be selected to define or be used for pacing and sensing vectors. Furthermore, any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, and 58, when not used for delivering pacing therapy, may be used to sense electrical activity during pacing therapy.

[0085] For reference Figure 7A In further detail, the housing 60 may encapsulate a therapy delivery module, which may include a stimulation generator for generating cardiac pacing pulses and defibrillation or cardioversion shocks, and a sensing module for monitoring electrical signals of the patient's heart (e.g., the patient's heart rhythm). Leads 18, 20, and 22 may also include elongated electrodes 62, 64, and 66, respectively, which may be in the form of coils. The IMD 16 may deliver defibrillation shocks to the heart 12 via any combination of the elongated electrodes 62, 64, and 66 and the housing electrode 58. Electrodes 58, 62, 64, and 66 may also be used to deliver cardioversion pulses to the heart 12. Furthermore, electrodes 62, 64, and 66 may be made of any suitable conductive material, such as, but not limited to, platinum, platinum alloys, and / or other materials known to be suitable for use in implantable defibrillation electrodes. Since electrodes 62, 64, and 66 are not typically configured for delivering pacing therapy, any of electrodes 62, 64, and 66 can be used to sense electrical activity and can be used in combination with any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, and 58. In at least one embodiment, the RV elongated electrode 62 can be used to sense the electrical activity of a patient's heart during pacing therapy delivery (e.g., in combination with the housing electrode 58 or a defibrillator electrode-to-housing electrode vector).

[0086] Figures 6 to 8B The configuration of the illustrative therapy system 10 shown is merely an example. In other examples, instead... Figure 6 As shown by transvenous leads 18, 20, 22, or others, the therapy system may include epicardial leads and / or patch electrodes. Additionally, in other examples, the therapy system 10 may be implanted in / around the cardiac space without transvenous leads (e.g., leadless / wireless pacing system), or leads may be implanted (e.g., transvenous implantation or using other methods) into the left ventricle of the heart (in addition to or replacing...). Figure 6(As shown, a transvenous lead is placed in the right ventricle). Furthermore, in one or more embodiments, the IMD 16 does not need to be implanted in the patient 14. For example, the IMD 16 can deliver various cardiac therapies to the heart 12 via percutaneous leads that extend through the skin of the patient 14 to multiple locations within or outside the heart 12. In one or more embodiments, the system 10 can utilize wireless pacing (e.g., using energy transfer to an intracardiac pacing component via ultrasound, inductive coupling, RF, etc.) and sense cardiac activation using electrodes on the canister / housing and / or subcutaneous leads.

[0087] In other examples of therapeutic systems that provide electrical stimulation to the heart 12, such systems may include any suitable number of leads coupled to the IMD 16, and each of the leads may extend to any location within or near the heart 12. Other examples of therapeutic systems may include, for instance, […]. Figures 6 to 8B The three transvenous leads shown are positioned as indicated. Furthermore, other therapeutic systems may include a single lead extending from IMD 16 into the right atrium 26 or the right ventricle 28, or two leads extending into one of the corresponding right atrium 26 and right ventricle 28.

[0088] Figure 8A This is a functional block diagram of an exemplary configuration of the IMD 16. As shown, the IMD 16 may include a control module 81, a therapy delivery module 84 (e.g., which may include a stimulation generator), a sensing module 86, and a power supply 90.

[0089] The control module or device 81 may include a processor 80, a memory 82, and a telemetry module or device 88. The memory 82 may include computer-readable instructions that, when executed, for example by the processor 80, cause the IMD 16 and / or control module 81 to perform various functions accorded to the IMD 16 and / or control module 81 as described herein. Further, the memory 82 may include any volatile, non-volatile, magnetic, optical, and / or electrical media, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and / or any other digital media. An exemplary capture management module may be a left ventricular capture management (LVCM) module, as described in U.S. Patent No. 7,684,863, entitled “LV THRESHOLDMEASUREMENT AND CAPTURE MANAGEMENT,” issued March 23, 2010.

[0090] The processor 80 of the control module 81 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), and / or equivalent discrete or integrated logic circuits. In some examples, the processor 80 may include multiple components, such as one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs and / or one or more FPGAs, and any combination of other discrete or integrated logic circuits. The functionality attributed herein to the processor 80 may be embodied in software, firmware, hardware, or any combination thereof.

[0091] The control module 81 controls the therapy delivery module 84 to deliver therapy (e.g., electrical stimulation therapy such as pacing) to the heart 12 according to one or more selected therapy programs that can be stored in the memory 82. More specifically, the control module 81 (e.g., processor 80) controls various parameters of the electrical stimulation delivered by the therapy delivery module 84, such as, for example, AV delay, VV delay, pacing pulses having amplitude, pulse width, frequency, or electrode polarity, etc., which can be specified by one or more selected therapy programs (e.g., AV and / or VV delay adjustment program, pacing therapy program, pacing recovery program, capture management program, etc.). As shown, the therapy delivery module 84 is electrically coupled to electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66, for example via conductors of the corresponding leads 18, 20, 22, or, in the case of housing electrode 58, via an electrical conductor disposed within the housing 60 of the IMD 16. The therapy delivery module 84 can be configured to generate electrical stimulation therapy, such as pacing therapy, using one or more of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, and 66 and deliver it to the heart 12.

[0092] For example, the therapy delivery module 84 may deliver pacing stimulation (e.g., pacing pulses) via loop electrodes 40, 44, 45, 46, 47, 48 and / or helical tip electrodes 42, 50 of leads 18, 22. Further, for example, the therapy delivery module 84 may deliver a defibrillation shock to the heart 12 via at least two of electrodes 58, 62, 64, 66. In some examples, the therapy execution module 84 may be configured to deliver pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other examples, the therapy delivery module 84 may be configured to deliver one or more of these types of stimulation in the form of other signals, such as sine waves, square waves, and / or other substantially continuous time signals.

[0093] The IMD 16 may further include a switching module 85, and the control module 81 (e.g., processor 80) may use the switching module 85 to select, for example via a data / address bus, which of the available electrodes are used for delivering therapy, such as pacing pulses for pacing therapy, or which of the available electrodes are used for sensing. The switching module 85 may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable for selectively coupling the sensing module 86 and / or the therapy delivery module 84 to one or more selected electrodes. More specifically, the therapy delivery module 84 may include a plurality of pacing output circuits. Each of these plurality of pacing output circuits may, for example, be selectively coupled using the switching module 85 to one or more of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 (e.g., a pair of electrodes for delivering therapy to a bipolar or multipolar pacing vector). In other words, each electrode may be selectively coupled using the switching module 85 to one of the pacing output circuits of the therapy delivery module.

[0094] The sensing module 86 is coupled (e.g., electrically coupled) to a sensing device, which, in addition to an additional sensing device, may include electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, and 66 to monitor the electrical activity of the heart 12 (e.g., electrocardiogram (ECG) / electrogram (EGM) signals). ECG / EGM signals can be used to measure or monitor activation time (e.g., ventricular activation time), heart rate (HR), heart rate variability (HRV), heart rate oscillation (HRT), deceleration / acceleration ability, deceleration sequence occurrence, T wave alternation (TWA), P wave to P wave interval (also known as PP interval or AA interval), R wave to R wave interval (also known as RR interval or VV interval), P wave to QRS complex interval (also known as PR interval, AV interval or PQ interval), QRS complex morphology, ST segment (i.e., the segment connecting the QRS complex and T wave), T wave changes, QT interval, electrical vector, etc.

[0095] The switching module 85 can also be used with the sensing module 86 to select which of the available electrodes is used or enabled to, for example, sense the electrical activity of a patient's heart (e.g., using one or more electrical vectors of the patient's heart using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66). Similarly, the switching module 85 can also be used with the sensing module 86 to select which of the available electrodes is not used (e.g., disabled) to, for example, sense the electrical activity of a patient's heart (e.g., using one or more electrical vectors of the patient's heart using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66), etc. In some examples, the control module 81 can select the electrode used as the sensing electrode via the switching module within the sensing module 86, for example, by providing a signal via a data / address bus.

[0096] In some examples, the sensing module 86 includes a channel comprising an amplifier having a relatively wider passband than an R-wave or P-wave amplifier. Signals from selected sensing electrodes can be supplied to a multiplexer and subsequently converted by an analog-to-digital converter into multi-bit digital signals for storage in memory 82, for example, as an electrogram (EGM). In some examples, such storage of an EGM in memory 82 may be under the control of direct memory access circuitry.

[0097] In some examples, the control module 81 may operate as an interrupt-driven device and may respond to interrupts from the pacemaker timing and control module, where the interruption may correspond to the occurrence of sensed P and R waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations may be performed by the processor 80, and any updates to values ​​or intervals controlled by the pacemaker timing and control module may occur after such interruptions. A portion of the memory 82 may be configured as multiple recirculation buffers capable of holding one or more series of measurement intervals that may be analyzed by, for example, the processor 80 in response to the occurrence of a pacing or sensing interruption to determine whether the patient's heart 12 is currently exhibiting atrial or ventricular tachyarrhythmias.

[0098] The telemetry module 88 of the control module 81 may include any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as a programmer. For example, under the control of the processor 80, the telemetry module 88 may receive downlink telemetry from the programmer and send uplink telemetry to the programmer via an antenna (which may be internal and / or external). The processor 80 may, for example, provide data to be uplinked to the programmer and control signals for the telemetry circuitry within the telemetry module 88 via an address / data bus. In some examples, the telemetry module 88 may provide the received data to the processor 80 via a multiplexer.

[0099] The various components of the IMD 16 are further coupled to a power source 90, which may include a rechargeable or non-rechargeable battery. A non-rechargeable battery may be selected to last for several years, while a rechargeable battery may be inductively charged from an external device, such as daily or weekly.

[0100] Figure 8B Another embodiment of the functional block diagram for the IMD 16 depicts bipolar RA lead 22, bipolar RV lead 18, and bipolar LV CS lead 20 without LA CS pacing / sensing electrodes, and is coupled to an implantable pulse generator (IPG) circuit 31 with programmable modes and parameters of the biventricular DDD / R type known in the pacing field. Furthermore, a sensor signal processing circuit 91 is indirectly coupled to a timing circuit 43 and coupled to a microcomputer circuit 33 via a data and control bus. The IPG circuit 31, shown in the functional block diagram, is generally divided into the microcomputer circuit 33 and the pacing circuit 21. The pacing circuit 21 includes a digital controller / timer circuit 43, an output amplifier circuit 51, a sensing amplifier circuit 55, an RF telemetry transceiver 41, an activity sensor circuit 35, and several other circuits and components described below.

[0101] Crystal oscillator circuit 89 provides a basic timing clock to pacing circuit 21, while battery 29 provides power. Power-on reset circuit 87 responds to the initial connection of the circuit with the battery to define initial operating conditions, and similarly resets the operating state of the device in response to the detection of a low battery condition. Reference mode circuit 37 generates a stable voltage reference and current for the analog circuitry within pacing circuit 21. Analog-to-digital converter (ADC) and multiplexer circuit 39 digitizes the analog signals and voltages to provide, for example, real-time telemetry of cardiac signals from sensing amplifier 55 for uplink transmission via RF transmitter and receiver circuit 41. Voltage reference and bias circuit 37, ADC and multiplexer 39, power-on reset circuit 87, and crystal oscillator circuit 89 may correspond to any of those used in exemplary implantable cardiac pacemakers.

[0102] If the IPG is programmed into a rate-response mode, signals output from one or more physiological sensors are used as rate control parameters (RCPs) to derive the physiological escape interval. For example, the escape interval is adjusted proportionally to the level of patient activity generated in the patient activity sensor (PAS) circuit 35 within the illustrated exemplary IPG circuit 31. The patient activity sensor 27 is coupled to the IPG housing and may take the form of a piezoelectric crystal transducer. The output signal of the patient activity sensor 27 can be processed and used as the RCP. Sensor 27 generates electrical signals in response to sensed body activity, which are processed by the activity circuit 35 and provided to the digital controller / timer circuit 43. The active circuit 35 and associated sensor 27 may correspond to circuits disclosed in the following U.S. patents: U.S. Patent No. 5,052,388, entitled “METHOD AND APPARATUS FOR IMPLEMENTING ACTIVITYSENSING IN A PULSE GENERATOR,” issued October 1, 1991, and U.S. Patent No. 4,428,378, entitled “RATE ADAPTIVE PACER,” issued January 31, 1984. Similarly, the exemplary systems, devices, and methods described herein may be practiced in conjunction with alternative types of sensors (such as oxygenation sensors, pressure sensors, pH sensors, and respiration sensors) to provide rate-responsive pacing capability. Alternatively, the QT time may be used as a rate indication parameter, in which case no additional sensor is required. Similarly, the exemplary embodiments described herein may also be practiced in non-rate-responsive pacemakers.

[0103] Data transmission to and from the external programmer is achieved via telemetry antenna 57 and an associated RF transceiver 41, which demodulates both received downlink telemetry and transmits uplink telemetry. Uplink telemetry capabilities may include the ability to transmit stored digital information, such as operating modes and parameters, EGM histograms and other events, as well as real-time EGM of atrial and / or ventricular electrical activity and marked channel pulses indicating sensed and paced depolarization occurring in the atria and ventricles.

[0104] The microcomputer 33 includes a microprocessor 80 and an associated system clock, as well as on-processor RAM chips 82A and ROM chips 82B. Additionally, the microcomputer circuitry 33 includes a separate RAM / ROM chip 82C to provide additional memory capacity. The microprocessor 80 typically operates in a low-power mode and is interrupt-driven. The microprocessor 80 is woken up in response to defined interrupt events, which may include A-TRIG, RV-TRIG, and LV-TRIG signals generated by timers in the digital timer / controller circuitry 43, and A-EVENT, RV-EVENT, and LV-EVENT signals generated by the sense amplifier circuitry 55. The specific values ​​of the timeout intervals and delays by the digital controller / timer circuitry 43 are controlled by the microcomputer circuitry 33 via data and control buses from programmed parameter values ​​and operating modes. Furthermore, if programmed to operate as a rate-responsive pacemaker, timing interrupts, such as every cycle or every two seconds, may be provided to allow the microprocessor to analyze active sensor data and update the basic AA, VA, or VV escape intervals (if applicable). In addition, the microprocessor 80 can also be used to define variable operational AV delay intervals, VV delay intervals, and energy delivered to each ventricle and / or atrium.

[0105] In one embodiment, microprocessor 80 is a custom microprocessor adapted to fetch and execute instructions stored in RAM / ROM unit 82 in a conventional manner. However, other embodiments are contemplated that may be suitable for practicing this disclosure. For example, readily available commercially available microprocessors or microcontrollers or custom-designed dedicated hardwired logic or state machine type circuitry may perform the functions of microprocessor 80.

[0106] The digital controller / timer circuit 43 operates under the general control of the microcomputer 33 to control timing and other functions within the pacing circuit 21, and includes a set of timing and associated logic circuits depicting certain related logic circuits relevant to this disclosure. The depicted timing circuits include a URI / LRI timer 83A, a VV delay timer 83B, an intrinsic interval timer 83C for timing the elapsed V-EVENT to V-EVENT interval or V-EVENT to A-EVENT interval or VV conduction interval, an escape interval timer 83D for timing the AA, VA, and / or VV pacing escape interval, an AV delay interval timer 83E for timing the A-LVp delay (or A-RVp delay) from a previous A-EVENT or A-TRIG, a postventricular timer 83F for timing the postventricular time period, and a date / time clock 83G.

[0107] The AV delay interval timer 83E is loaded with an appropriate delay interval (e.g., A-RVp delay or A-LVp) for a ventricular chamber to time out from a previous A-PACE or A-EVENT. The interval timer 83E triggers pacing stimulus delivery and can be based on one or more previous cardiac cycles (or an empirically derived dataset from a given patient).

[0108] The post-event timer 83F times out the post-ventricular time period following RV-EVENT, LV-EVENT, RV-TRIG, or LV-TRIG, and the post-atrial time period following A-EVENT or A-TRIG. The duration of the post-event time period can also be selected as a programmable parameter stored in the microcomputer 33. The post-ventricular time period includes PVARP, post-atrial ventricular blanking period (PAVBP), ventricular blanking period (VBP), post-ventricular atrial blanking period (PVARP), and ventricular refractory period (VRP), although other time periods can be defined at least in part according to the operating circuitry used in the pacemaker. The post-atrial time period includes the atrial refractory period (ARP) and atrial blanking period (ABP). During the atrial refractory period, A-EVENT is ignored for the purpose of resetting any AV delays; during the atrial blanking period, atrial sensing is disabled. It should be noted that the onset of the post-atrial time interval and the AV delay may begin substantially simultaneously with the start or end of each A-EVENT or A-TRIG, or in the latter case, at the end of the A-PACE following the A-TRIG. Similarly, the onset of the post-ventricular time interval and the VA escape interval may begin substantially simultaneously with the start or end of the V-EVENT or V-TRIG, or in the latter case, at the end of the V-PACE following the V-TRIG. The microprocessor 80 also optionally calculates the AV delay, VV delay, post-ventricular time interval, and post-atrial time interval, which vary with the sensor-based escape interval established in response to the RCP and / or with inherent atrial and / or ventricular rates.

[0109] Output amplifier circuit 51 includes an RA pacing pulse generator (and an LA pacing pulse generator if LA pacing is provided), an RV pacing pulse generator, an LV pacing pulse generator, and / or any other pulse generator configured to provide atrial and ventricular pacing. To trigger the generation of an RV-PACE or LV-PACE pulse, digital controller / timer circuit 43 generates an RV-TRIG signal upon A-RVp delay timeout (in the case of RV pre-excitation), or an LV-TRIG signal upon A-LVp delay timeout (in the case of LV pre-excitation) provided by AV delay timer 83E (or VV delay timer 83B). Similarly, digital controller / timer circuit 43 generates an RA-TRIG signal (or an LA-TRIG signal, if provided), to trigger the output of an RA-PACE pulse, at the end of a VA escape interval timed by escape interval timer 83D.

[0110] Output amplifier circuit 51 includes switching circuitry for coupling pacing electrode pairs selected from lead conductors and IND-CAN electrodes 20 to RA pacing pulse generators (and LA pacing pulse generators, if provided), RV pacing pulse generators, and LV pacing pulse generators. Pacing / sensing electrode pair selection and control circuitry 53 selects lead conductors and associated pacing electrode pairs for coupling with atrial and ventricular output amplifiers within output amplifier circuitry 51 to achieve RA, LA, RV, and LV pacing.

[0111] Sensing amplifier circuit 55 contains sensing amplifiers for atrial and ventricular pacing and sensing. High-impedance P-wave and R-wave sensing amplifiers are used to amplify the voltage difference signal generated on the sensing electrode pair due to the passage of the cardiac depolarization wavefront. The high-impedance sensing amplifier uses high gain to amplify low-amplitude signals and relies on passband filtering, time-domain filtering, and amplitude threshold comparison to distinguish the P-wave or R-wave from background electrical noise. Digital controller / timer circuit 43 controls the sensitivity settings of atrial and ventricular sensing amplifier 55.

[0112] During the blanking period before, during, and after the delivery of a pacing pulse to any of the pacing electrodes in the pacing system, the sensing amplifier can be decoupled from the sensing electrode to avoid sensing amplifier saturation. Sensing amplifier circuit 55 includes blanking circuitry for decoupling the selected lead conductor pair and IND-CAN electrode 20 from the inputs of the RA sensing amplifier (and LA sensing amplifier, if provided), RV sensing amplifier, and LV sensing amplifier during ABP, PVABP, and VBP. Sensing amplifier circuit 55 also includes switching circuitry for coupling the selected sensing electrode lead conductor and IND-CAN electrode 20 to the RA sensing amplifier (and LA sensing amplifier, if provided), RV sensing amplifier, and LV sensing amplifier. Similarly, sensing electrode selection and control circuitry 53 selects conductors and associated sensing electrode pairs for coupling with the atrial and ventricular sensing amplifiers within output amplifier circuit 51 and sensing amplifier circuit 55 to achieve RA, LA, RV, and LV sensing along desired unipolar and bipolar sensing vectors.

[0113] Right atrial depolarization or a P wave in the RA-SENSE signal sensed by the RA sensing amplifier generates the RA-EVENT signal, which is transmitted to the digital controller / timer circuit 43. Similarly, left atrial depolarization or a P wave in the LA-SENSE signal sensed by the LA sensing amplifier (if provided) generates the LA-EVENT signal, which is transmitted to the digital controller / timer circuit 43. Ventricular depolarization or an R wave in the RV-SENSE signal is sensed by the ventricular sensing amplifier, generating the RV-EVENT signal, which is transmitted to the digital controller / timer circuit 43. Similarly, ventricular depolarization or an R wave in the LV-SENSE signal is sensed by the ventricular sensing amplifier, generating the LV-EVENT signal, which is transmitted to the digital controller / timer circuit 43. The RV-EVENT, LV-EVENT, RA-EVENT, and LA-SENSE signals can be refractory or non-refractory and can be unintentionally triggered by electrical noise signals or abnormally occurring depolarization waves instead of actual R or P waves.

[0114] The technologies described in this disclosure, including those attributed to IMD 16, computing device 140, and / or various constituent components, can be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, aspects of these technologies can be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuits, and any combination of such components embodied in a programmer, such as a physician or patient programmer, stimulator, image processing device, or other device. The terms “module,” “processor,” or “processing circuit” can generally refer to any of the aforementioned logic circuits, alone or in combination with other logic circuits, or any other equivalent circuit.

[0115] Such hardware, software, and / or firmware may be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the units, modules, or components may be implemented together or separately as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.

[0116] When implemented in software, the functions of the systems, apparatuses, and techniques described herein may be embodied in instructions on a computer-readable medium, such as RAM, ROM, NVRAM, EEPROM, flash memory, magnetic data storage media, optical data storage media, etc. These instructions may be executed by processing circuitry and / or one or more processors to support one or more aspects of the functions described herein.

[0117] Exemplary implementation plan

[0118] Implementation Scheme 1: A system for cardiac assessment, the system comprising:

[0119] a. An electrode device comprising a plurality of external electrodes for monitoring electrical activity from patient tissues;

[0120] b. A communication interface that receives cardiac information from at least one medical device; and

[0121] c. A computing device, the computing device including processing circuitry and operatively coupled to the electrode device and the communication interface, the computing device being configured to:

[0122] d. Monitor electrical activity using the plurality of external electrodes.

[0123] e. Receive supplemental cardiac data from at least one medical device via the communication interface, and

[0124] f. Synchronize the monitored electrical activity or data based on the monitored electrical activity with the supplemental cardiac data to generate synchronized cardiac information.

[0125] Implementation Scheme 2: A method for cardiac assessment, the method comprising:

[0126] a. Use multiple external electrodes to monitor electrical activity from patient tissues;

[0127] b. Receive supplemental cardiac data from at least one medical device; and

[0128] c. Synchronize the monitored electrical activity or data based on the monitored electrical activity with the supplementary cardiac data to generate synchronized cardiac information.

[0129] Implementation Scheme 3: The system or method according to any one of Implementation Schemes 1 to 2, wherein the supplemental cardiac data includes one or more markers indicating the occurrence of cardiac events.

[0130] Implementation Scheme 4: The system or method according to Implementation Scheme 3, wherein the one or more markers include one or more markers indicating intrinsic atrial depolarization, atrial pacing, atrial premature beat complex, intrinsic ventricular depolarization, ventricular pacing, ventricular premature beat complex, ventricular repolarization during intrinsic or pacing ventricular events, effective ventricular or atrial capture, ineffective ventricular or atrial capture, valvular closure, valvular opening, systole, and diastole.

[0131] Implementation Scheme 5: A system or method according to any one of Implementation Schemes 1 to 4, wherein the supplemental cardiac data represents at least one of cardiac electrical signals, heart sounds, cardiac pressure, blood flow, and estimated instantaneous flow waveforms provided by the left ventricular assist device.

[0132] Implementation Scheme 6: A system or method according to any one of Implementation Schemes 1 to 5, wherein the system further includes a display comprising a graphical user interface for presenting information to assist the user in at least one of assessing a patient’s cardiac health, evaluating and adjusting cardiac therapies delivered to the patient, and navigating at least one implantable electrode to a region of the patient’s heart, wherein the computing device is operatively coupled to the display and further configured to perform, or the method further includes displaying at least a portion of the monitored electrical activity or data based thereon annotated with at least a portion of the supplemental cardiac data on the graphical user interface.

[0133] Implementation Scheme 7: A system or method according to any one of Implementation Schemes 1 to 6, wherein the computing device is further configured to perform or the method further includes determining at least one interval between a first event indicated by the monitored electrical activity and a second event indicated by the supplemental cardiac data.

[0134] Implementation Scheme 8: A system or method according to any one of Implementation Schemes 1 to 7, wherein the computing device is further configured to perform or the method further includes modifying the monitored electrical activity based on the supplementary cardiac data.

[0135] Implementation Scheme 9: The system or method according to Implementation Scheme 8, wherein modifying the monitored electrical activity based on the supplementary cardiac data includes ignoring the monitored electrical activity for a selected time period following ventricular pacing indicated by the supplementary cardiac data.

[0136] Implementation Scheme 10: The system or method according to any one of Implementation Schemes 1 to 9, wherein the at least one medical device includes an implantable medical device.

[0137] Implementation Scheme 11: The system or method according to any one of Implementation Schemes 1 to 10, wherein the at least one medical device comprises at least one of a cardiac pacemaker, a left ventricular assist device, a cardioverter defibrillator, a subcutaneous monitoring device, and an intracardiac pressure sensor.

[0138] Implementation Scheme 12: A system for cardiac assessment, the system comprising:

[0139] a. An electrode device comprising a plurality of external electrodes for monitoring electrical activity from patient tissues;

[0140] b. A communication interface that receives cardiac information from at least one medical device;

[0141] c. A display comprising a graphical user interface for presenting information to assist the user in at least one of assessing a patient's cardiac health and evaluating and adjusting cardiac therapies delivered to the patient, and

[0142] d. A computing device, the computing device including processing circuitry and operatively coupled to the electrode device and the communication interface, the computing device being configured to:

[0143] e. Use the aforementioned plurality of external electrodes to monitor electrical activity.

[0144] f. Receive supplemental cardiac data from at least one medical device via the communication interface.

[0145] g. Synchronizing the monitored electrical activity, or data based on the monitored electrical activity, with the supplemental cardiac data to generate synchronized cardiac information, and

[0146] h. Display on the graphical user interface at least a portion of the monitored electrical activity or data based thereon annotated with at least a portion of the supplementary cardiac data.

[0147] This disclosure is provided with reference to exemplary embodiments and is not intended to be limiting. As previously described, those skilled in the art will recognize that various other exemplary applications can utilize the beneficial features of the devices and methods described herein using the techniques described herein. Various modifications to the exemplary embodiments and additional embodiments of this disclosure will be apparent from this specification.

Claims

1. A system for cardiac assessment, the system comprising: An electrode device comprising a plurality of external electrodes for monitoring electrical activity from patient tissues; A communication interface that receives cardiac information from at least one medical device; and A computing device, including processing circuitry and operatively coupled to the electrode device and the communication interface, is configured to: Electrical activity is monitored using the aforementioned external electrodes. Receive supplemental cardiac data from at least one medical device via the communication interface, and The monitored electrical activity, or data based on the monitored electrical activity, is synchronized with the supplementary cardiac data to generate synchronized cardiac information. The computing device is further configured to modify the monitored electrical activity based on synchronously supplemented cardiac data.

2. The system of claim 1, wherein the supplemental cardiac data includes one or more markers indicating the occurrence of cardiac events.

3. The system of claim 2, wherein the one or more markers include one or more markers indicating intrinsic atrial depolarization, atrial pacing, atrial premature beat complex, intrinsic ventricular depolarization, ventricular pacing, ventricular premature beat complex, ventricular repolarization during intrinsic or pacing ventricular events, effective ventricular or atrial capture, ineffective ventricular or atrial capture, heart valve closure, heart valve opening, systole, and diastole.

4. The system of claim 1, wherein the supplemental cardiac data represents at least one of cardiac electrical signals, heart sounds, cardiac pressure, blood flow, and estimated instantaneous flow waveforms provided by the left ventricular assist device.

5. The system of claim 1, further comprising a display including a graphical user interface for presenting information to assist the user in at least one of assessing a patient's cardiac health, evaluating and adjusting cardiac therapies delivered to the patient, and navigating at least one implantable electrode to a region of the patient's heart, wherein the computing device is operatively coupled to the display and further configured to: The graphical user interface displays at least a portion of the monitored electrical activity or data based thereon annotated with at least a portion of the supplementary cardiac data.

6. The system of claim 1, wherein the computing device is further configured to determine at least one interval between a first event indicated by the monitored electrical activity and a second event indicated by the supplemental cardiac data.

7. The system of claim 1, wherein modifying the monitored electrical activity based on the supplemental cardiac data includes ignoring the monitored electrical activity for a selected time period following ventricular pacing indicated by the supplemental cardiac data.

8. The system of claim 1, wherein the at least one medical device comprises an implantable medical device.

9. The system of claim 1, wherein the at least one medical device comprises at least one of a cardiac pacing device, a left ventricular assist device, a cardioverter defibrillator, a subcutaneous monitoring device, and an intracardiac pressure sensor.

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